NL-OMON54969已完成不适用
A double-blind, placebo-controlled, randomized clinical pharmacology study to evaluate the prevention effect and the recovery-promoting effect of a single subcutaneous administration of GYM329 on disuse muscle atrophy in healthy male volunteers. - CS0355-200321
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Able and willing to provide written informed consent and to comply with the
- •study protocol.
- •Healthy men aged from 18 to less than 40 years at the time of consent.
- •Right leg dominant.
- •Agreement to limit physical activity as directed by study site staff from the
- •time of informed consent until the end of the muscle strength evaluation period
- •(completion of Day 43).
- •Body mass index (BMI; weight in kg divided by height in meters squared) is
- •between 18.5 and less than 25.0 at screening.
排除标准
- •Current cardiovascular disorder, renal disorder, hepatic disorder,
- •gastrointestinal disorder, hematologic disorder, immune disorder, neurologic
- •disorder, endocrine disorder, metabolic disorder, or pulmonary disorder or a
- •history of clinical significance for any of these disorders and impaired renal,
- •hepatic, or
- •cardiopulmonary function, as judged by the investigator.
- •History of congenital myopathy.
- •Congenital thrombophilia.
- •Previous or current VTE.
- •History of hip or limb surgery, spine or spinal cord surgery, or laparotomy
- •(excluding laparotomy for appendicitis or inguinal hernia), or laparoscopic
- •surgery (e.g. cholecystectomy).
研究者
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